Ethical, legal, and social issues (ELSI) and reporting guidelines of AI research in healthcare

This paper aims to (1) summarize the descriptions of ethical, legal, and social issues (ELSI) in major reporting guidelines, identify trends and tendencies, and (2) highlight issues for future researchers and guideline creators.

performed this work, and after both verified the consistency, the results are listed in Table 2.The obtained results, including the clinician's perspective on SK, were examined, and two major issues were identified.

The necessity of efforts for further practical guidance in cooperation with society and patients
Prominently, "V.Address biases" (seven guidelines) were mentioned in the reporting guidelines.However, the purpose and awareness of the issue were unclear in several studies.Recently, the issues of bias surrounding AI have garnered increasing attention in addition to scientific imperatives, owing to its impact on ELSI.For example, biases in data, design and interpretation, and beneficiary exist [4,15].Considering the diverse concerns surrounding bias, further enhancements are required to support the efforts of researchers.
In addition, as shown in Table 2, an increasingly mentioned item in the guidelines is "III.Defining relevant ethical issues through consultation," which includes patient and public involvement (PPI) awareness.Precisely, a strong sense of crisis has arisen regarding ELSI, such that the design bias of medical AI and data may directly develop into discrimination and disparities in the recipients of health care [15].The same purpose is applicable for "II.Engage multiple stakeholders and understand the context."and "XI.Evaluate and improve performance."Researchers are required to recognize the growing concerns and incorporate the perspective of potential medical AI targets in their R&D processes.To help researchers smoothly develop such initiatives, highly practical guidance content from guideline creators is needed.

Limitations of guidelines and the need for researchers to take the initiative
In the AI reporting guidelines for R&D, items with few checks were identified; overall, ELSI items lagged behind while being addressed.Particularly, "VI.Privacy by Design and Privacy by Default" and "VII.Identify regulatory requirements" were significant, and both were met only in one or two guidelines.
Despite the large amount of detailed personal data handled in AI research, reporting guidelines did not include a section addressing data-protection measures.Globally, personal data protection in research activities is highly concerning, and reporting guidelines require the consideration of issues and alerting researchers.However, the legal requirements for personal-information protection may differ from country to country, and reporting guidelines may offer limitations in providing detailed guidance on the matter for individual research reports.While addressing privacy and legal requirements, researchers should not solely rely on the reporting guidelines but should consider proactive consultation with experts and ethical review committees, such that the legal and ethical measures remain relevant to their plans.The point "IX.Adopt standards and best practices" is as mentioned above, and the lack of reference to best practices in R&D was assumed as a limitation of the guidelines for reporting papers.
ELSI surrounding medical AI are evolving and becoming more inclusive, even in the early stages of R&D.The "Reporting Guidelines" not only present the methods to write papers, but also consider the meaning of ELSI guidelines that link researchers, medical care, and patients.A continuous review of reporting guidelines is essential to ensure that medical AI continues to develop with the support of people.
Moreover, as a next step, it is also important to promote harmonization among guidelines, and for reporting guidelines to be linked to discussions on AI practice in the clinical aspect.In doing so, we hope that the ELSI aspect of the discussion, as described in this paper, will be developed in a way that includes the perspectives of many stakeholders.

Table 2 . ELSI perspectives on reporting guidelines for the R&D of AI technology in healthcare. Reporting guideline acronym /Date of publication Targeted readers
[4]m ethics and governance of artificial intelligence for health: WHO guidance[4]Annex, Considerations for the ethical design, development and use of artificial intelligence for health "Considerations for AI developers," the following 11 items were used in the analysis as ELSI perspectives.I.Clarify the objectives II.Engage multiple stakeholders and understand contexts III.Define relevant ethical issues through consultation IV.Assess risks V.Address biases VI.Privacy by design and privacy by default VII.Identify regulatory requirements VIII.Establish data management plans IX.Adopt standards and best practices X.Engage * and educate multiple stakeholders for deployment and maintenance XI.Evaluate and improve performance † Three reports are documented over 2021-2023; the 2022 report is the central document that proposes the checklist.‡ Stakeholders involved in the development of the guidelines.There are no specifications for the targeted reader https://doi.org/10.1371/journal.pdig.0000607.t002